Proteus Digital Health®, Inc. released new data demonstrating the efficacy of DigiMedstm in treating Hepatitis C patients at high risk for nonadherence. Dr. Mark Sulkowski, MD, Professor of Medicine at John Hopkins University School of Medicine, the principal investigator for the study, presented the findings at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, in Boston, titled, Efficacy and Adherence to Oral Hepatitis C (HCV) Treatment Through a Digital Medicine Program (DMP) Among a Population at High Risk for Nonadherence. The study examined the impact of a digital medicine program (DMP) on the efficacy of, and adherence to, direct acting antivirals (DAA) in Hepatitis C patients at risk for nonadherence.
Study results showed that 99% of all participants with sustained virologic response (SVR) assessed > 10 weeks after completion of therapy achieved SVR. The overall median adherence rate was 95%, where similar populations have shown adherence rates of less than 60%. Patient satisfaction survey data showed more than 80% of respondents agreed that Proteus DigiMedstm helped them keep track of their medications, feel more connected to their care team and feel motivated to achieve their treatment goals.
It is estimated that of the 4.29 million prevalent HCV cases in 2018, only about 37% have been cured. For those patients who have been diagnosed, access to treatment may be restricted due to the high cost of DAA medications and perceived risk factors for nonadherence. A recent study highlighted as many as 80% of DAA-eligible patients were unable to receive treatment due to factors such as concurrent psychiatric illnesses, active substance abuse or nonadherence and missed clinic visits.
"This data demonstrates that Proteus DigiMedstm may be used to support adherence and optimize cure rates in difficult to treat HCV populations," said Dr. George Savage, Chief Medical Officer of Proteus. "This information adds to the evidence showing long-term, positive patient outcomes for underserved populations, that without a DMP often do not get access to these curative treatments."
The prospective, single-arm, open-label, multicenter study across 18 U.S. clinics followed 288 adults during treatment with oral direct-acting antivirals (DAAs) co-encapsulated with DigiMedstm. The criteria for patient inclusion in the study required one or more risk factors for nonadherence, including: active alcohol or substance use, hospitalization within two years for psychiatric comorbidity, evidence of nonadherence to medication, history of missed clinic visits for hepatitis management, or patient-reported transportation barriers. Of the 288 adult participants, 61% had a psychiatric disorder (23% of which had a serious mental illness and 52% had alcohol or substance abuse). Most participants had a household income of less than $24,999.
"This is encouraging data showing how DigiMedstm can make a significant impact on curing patients at high risk of nonadherence," said Andrew Thompson, CEO of Proteus Digital Health. "As we pursue the use of DigiMedstm across therapeutic areas, we believe we will continue to see improved patient outcomes."
The Proteus DMP is a digital medicine offering that measures medication treatment effectiveness and helps physicians improve clinical outcomes. DigiMedstm have been used in patients with cardio metabolic conditions including hypertension, hypercholesterolemia and type 2 diabetes; Hepatitis C; Tuberculosis; HIV; and colorectal cancer.
About Proteus Digital Health®
Proteus Digital Health is enabling a new category of pharmaceuticals: Digital Medicines. These include widely used drugs, formulated so they communicate when they have been ingested; a wearable patch that detects medicines and captures physiologic response; mobile applications to support patient self-care and physician decision-making; and data analytics to serve the needs of health system managers. The company has more than 540 issued patents that protect this enabling technology, and regulatory clearances in the U.S., European Union and China. Proteus Digital Health is privately held.
For more information, please visit www.proteus.com.
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